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Completed

NCT Number: NCT05543746

Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression

This is a feasibility study of performing repeated EEG recordings and assessment of affective states during open-label administration of BRX to women with postpartum depression. Study phases will include screening, enrollment, intervention, and follow-up. Subjects will be screened for study eligibility criteria through clinical assessments and self-report. Enrolled subjects will be admitted to the UNC Women's Hospital, where five serial EEG recordings will be obtained, along with frequent assessments of affective state, before, during, and after a 60-hour IV infusion of BRX. Follow-up procedures will include assessments of PPD and affective symptoms, as well as an exit interview with the study team. If feasibility outcomes are achieved, exploratory EEG analyses will be performed with AMICA (adaptive mixture independent component analysis), community detection, and microstate assessment. Exploratory analyses of data collected by facial expression detection software (iMotions Affectiva) are also planned.

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Key information

Conditions

Postpartum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent.
  • Documented proof of full COVID-19 vaccination
  • Ambulatory, female, aged 18-45
  • ≤ 8 months postpartum
  • Agrees to adhere to the study requirements.
  • Onset of depression in 3rd trimester or within 4 weeks of delivery
  • Meets DSM-V criteria for major depressive disorder with peripartum onset.
  • 17-item HAM-D total score ≥20 at screening
  • Stopped breastfeeding or agrees to temporarily stop for 7 days including 4 days of hospitalization and 3 days after
  • No new psychotropic drugs during screening and active treatment of study
  • Stable use of any current psychotropic drugs for at least 28 days prior to enrollment, with stable dosage for at least 14 days prior to enrollment
  • Must be on documented contraceptive.
  • Must have a caregiver or family member with them to help care for the subject's child(ren) during the infusion and to be in the room with the subject if the child(ren) are present during the infusion

Exclusion criteria

  • Positive pregnancy test at screening or day 1
  • Pregnancy that resulted in a stillbirth, termination, or child that was placed for adoption.
  • Renal impairment or failure, hepatic impairment or failure, or anemia
  • Untreated or inadequately treated hypothyroidism or hyperthyroidism
  • Known allergy to progesterone or allopregnanolone.
  • Suicide attempt at this episode
  • Medical history of schizophrenia, and/or schizoaffective disorder
  • Current psychotic symptoms including delusions, hallucinations, or formal thought disorder.
  • Concurrent substance abuse
  • Exposure to another investigational medication or device within 30 days
  • Has previously participated in any study employing brexanolone or SAGE-217.
  • Subject is investigative site personnel, sponsor personnel, or an immediate member of their family.
  • Has received electroconvulsive therapy during current episode.
  • History of seizure disorder
  • On anticonvulsant agents
  • On benzodiazepines

Treatment and study plan

Brexanolone

Drug

Enrolled subjects will receive a 60-hour infusion of Brexanolone (BRX) according to FDA approved protocol for administration. A programmable peristaltic infusion pump will be used to ensure accurate delivery.

Other names: Zulresso

Primary outcomes

  1. Number of Successfully Analyzed EEG Recordings

    Time frame: 4 days

    Feasibility of EEG recordings. Each participant was scheduled to have 5 EEG recordings.

  2. Number of Subjects Completing the Entire Study Protocol Through the Follow-up Phase

    Time frame: 30 days

    Feasibility of study completion

  3. Number of Subjects Withdrawn From Protocol Due to Adverse Events or Participation Burden

    Time frame: 30 days

    Feasibility of subject burden

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Baszucki Brain Research Fund
  • Sage Therapeutics

Registry information

Official study title

Dynamic Neural Mechanisms of Brexanolone-induced Antidepressant Effects in Postpartum Depression: a Feasibility Study

Acronym: BRX-PPD

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 16, 2022
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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